(139 days)
No
The document describes a continuous flow anesthesia system and an optional module for delivering CO2. There is no mention of AI or ML in the intended use, device description, or the specific sections for AI/ML mentions.
No.
The device is an anesthesia system used for delivering gases and monitoring vital signs during anesthesia, not for treating a disease or condition itself.
No
The device is described as an anesthesia system and a module for delivering medical gas, primarily focusing on ventilation and delivery of anesthetic agents and gases. While it monitors some physiological parameters (oxygen, CO2 concentrations, breathing pressure, respiratory volume), this monitoring is for controlling the delivery of gases and agents during anesthesia, not for diagnosing a patient's medical condition.
No
The device description explicitly details hardware components like flow and pressure control, a control knob, flow and pressure measurement, a mounting means for a CO2 cylinder, and an enclosure. This indicates it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "continuous flow anesthesia system" used for delivering gases, anesthetic vapor, and monitoring physiological parameters within the patient's breathing circuit.
- Device Description: The description focuses on the delivery and control of medical gases and anesthetic agents.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose diseases or other conditions. This device's function is related to supporting and monitoring a patient during anesthesia, which is a clinical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Primus US "Apollo" is indicated as a continuous flow anesthesia system. The Primus US "Apollo" may be used for manually assisted, or automatic ventilation, and delivery of gases (O2, N2O and CO2 - in combination with the CO2 module [i.e. Fourth Gas Module]), anesthetic vapor, and monitoring of oxygen and CO2 concentrations, breathing pressure, respiratory volume, and anesthetic agent identification and concentration. Federal law restricts this device to sale by or on the order of a physician.
Product codes
73BSZ
Device Description
The Fourth Gas Module provides an optional means of delivering carbon dioxide (CO2) into the fresh gas coming from the gas mixer of the anesthesia machine Primus US "Apollo".
The Fourth Gas Module consists of a means of flow and pressure control for CO-; a colorcoded control knob; a means of flow and pressure measurement for CO;; a means to mount a CO2 E-size cylinder; and an enclosure for the various components.
The Fourth Gas Module has been verified to provide the Primus US "Apollo" anesthesia workstation (K042607) with a means of delivering carbon dioxide as a medical gas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design, development, verification and validation of the device was performed in accordance with FDA regulations and guidance and company internal standards. The testing and analysis of results provide assurance that the device meets its specifications and is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image shows the logo for Dräger medical, which is a company that specializes in medical and safety technology. Below the logo, it says "A Dräger and Siemens Company". Above the logo, there is a handwritten number that appears to be "K081447".
510(k) Summary
Summary of Safety and Effectiveness
Applicants Name and Address
Draeger Medical AG & Co. KG Moislinger Allee 53-55 D-23542 Luebeck Germany
Applicants Contact Person
Dr. Karin Luebbers Senior Manager Regulatory Affairs
011 49 (451) 882-5367 Tel. No.: 011 49 (451) 882-7-5367 Fax No.:
Applicants US Contact Person
Ms Joyce Kilrov Vice President, Processes, Quality & Regulatory
Tel. No.: (215) 660-2626 Fax No.: (215) 721-5424
Date the Summary was prepared
September 29, 2008
Device Name
Trade Name: Common Name: Fourth Gas Module with CO2 for Primus US "Apollo" Anesthesia machine
Classification
| Regulation No. | Device | Product Code |
|---|---|---|
| 868.5160 | Gas Machine - Anesthesia | 73BSZ |
Legally marketed device to which Substantial Equivalence is claimed
| Aestive/5 Anesthesia System | GE Datex-Ohmeda, USA |
|---|---|
| Ohmeda Excel 3000 Anesthesia System | Ohmeda, USA |
1
Image /page/1/Picture/1 description: The image shows the logo for Dräger medical. The word "Dräger" is in a bold, sans-serif font, with the two dots above the "a" in "Dräger" being prominent. To the right of "Dräger" is the word "medical" in a thinner, sans-serif font. Below the logo is the text "A Dräger and Siemens Company" in a smaller font.
Description of the Device
The Fourth Gas Module provides an optional means of delivering carbon dioxide (CO2) into the fresh gas coming from the gas mixer of the anesthesia machine Primus US "Apollo".
The Fourth Gas Module consists of a means of flow and pressure control for CO-; a colorcoded control knob; a means of flow and pressure measurement for CO;; a means to mount a CO2 E-size cylinder; and an enclosure for the various components.
The Fourth Gas Module has been verified to provide the Primus US "Apollo" anesthesia workstation (K042607) with a means of delivering carbon dioxide as a medical gas.
Intended Use
The Primus US "Apollo" is indicated as a continuous flow anesthesia system. The Primus US "Apollo" may be used for manually assisted, or automatic ventilation, and delivery of gases (O2, N2O and CO2 - in combination with the CO2 module [i.e. Fourth Gas Module]), anesthetic vapor, and monitoring of oxygen and CO2 concentrations, breathing pressure, respiratory volume, and anesthetic agent identification and concentration. Federal law restricts this device to sale by or on the order of a physician.
Substantial Equivalence
The Fourth Gas Module with CO2 for Primus US "Apollo" is substantially equivalent to the following devices:
| DEVICE | 510(k) NUMBER |
|---|---|
| Aestiva/5 Anesthesia System | K000706 |
| Ohmeda Excel 3000 Anesthesia System | K973896 |
The Fourth Gas Module with CO2 for Primus US "Apollo" provides, as does the Aestive/5 or the Excel 3000, a mechanical means of delivering CO2 into the fresh gas coming from the anesthesia machine. The Fourth Gas Module is optionally available right from the manufacturer or available as an upgrade. The ambient conditions of the devices differ slightly. but remain comparable.
Like its predicate Aestival5 or Excel 3000, the Fourth Gas Module receives carbon dioxide gas from an externally mounted gas cylinder equipped with a pressure requlator and adds it to the anesthetic gas coming from the mixer of the anesthesia machine. As a means to prevent hypoxic gas mixtures, the Fourth Gas Module for Primus US "Apollo" provides an ORC function as does the Aestive/5.
2
The technical characteristics of the Fourth Gas Module with CO2 for Primus US "Apollo" do not raise new questions regarding safety or effectiveness. Furthermore, the labeling provides similar information as the predicate device.
Information provided in the 510(k) Premarket Notification supports the determination of substantial equivalence. Design, development, verification and validation of the device was performed in accordance with FDA regulations and guidance and company internal standards. The testing and analysis of results provide assurance that the device meets its specifications and is safe and effective for its intended use.
In summary, Draeger Medical AG & Co. KG has demonstrated that the Fourth Gas Module with CO2 for Primus US "Apollo" is safe and effective. It is considered to be substantial equivalent to currently marketed predicate devices which have been previously cleared by the FDA.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 0 8 2008
Dr. Karin Luebbers Senior Manager Regulatory Affairs Dräger Medical AG & Co. KG 53/55 Moislinger Allee Luebeck GERMANY 23542
Re: K081447
Trade/Device Name: Fourth Gas Module with CO2 for Primus US "Apollo" Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: September 30, 2008 Received: October 2, 2008
Dear Dr. Luebbers:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Dr. Luebbers
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market,
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
W.H. Arnolds Lend m. D
for 4
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): ________________
Device Name: Fourth Gas Module with CO2 for Primus US "Apollo"
Indications for Use:
The Primus US "Apollo" is indicated as a continuous flow anesthesia system. The Primus US "Apollo" may be used for manually assisted, or automatic ventilation, and delivery of gases (O2, N2O and CO2 - in combination with the CO2 module [i.e. Fourth Gas Module]), anesthetic vapor, and monitoring of oxygen and CO2 concentrations, breathing pressure, respiratory volume, and anesthetic agent identification and concentration. Federal law restricts this device to sale by or on the order of a physician.
L. Arimid.
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: }- 0 8 | 447
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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